Biopharmaceutical company ARS Pharmaceuticals, Inc. (SPRY), Monday announced positive efficacy results in its phase 2 inpatient chronic spontaneous urticaria study with neffy (epinephrine nasal spray), an investigational new drug.
The trial met its primary endpoints with both 1 mg and 2 mg neffy demonstrating statistically significant and clinically meaningful changes from baseline in itch, hives, urticaria and erythema scores as early as 5 minutes after dosing.
Urticaria is a skin disorder that causes itchy hives and/or angioedema; 50% of chronic urticaria cases are non-responsive to first-line antihistamine therapy.
"The Phase 2 results in this highly refractory patient population are impressive and encouraging as they indicate neffy could be a game-changing therapeutic advance in the treatment of urticaria," says David Bernstein, Emeritus Professor of Pediatrics at the Cincinnati Children's Hospital Medical Center, a former member of the Joint Task Force on Practice Parameters (urticaria guidelines) and Principal Investigator of the Study. "Urticaria symptoms clear within minutes after dosing, and neffy could offer patients a novel treatment option to address existing gaps in the efficacy of currently available antihistamines or biologics."
Data supports continued development of neffy in urticaria with planned outpatient study in acute flares to initiate during 2024, with pivotal study to potentially initiate in 2025.
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